HeyJaredGareth Macdonald
- Indexed articles, last 90 days
- 35
- Latest publication
- Sep 30, 2026
- Outlet visibility, for SCM
- Top 10M sites
- Earliest in this view
- Jul 6, 2026
Latest articles
Clinical trials face mounting challenges (opens the original)
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A Bain survey of 120 industry professionals highlights mounting operational pressures and the growing influence of artificial intelligence tools. Patient recruitment is becoming more challenging, trial delays are more common, and research sites are struggling to meet growing sponsor and CRO demand, according to a new industry survey. The Bain & Company survey polled 120 sponsors, CROs, and trial site professionals about the operational difficulties facing the sector. Results found that a majorit
EMA Rejects FDA Single-Trial Drug Approval Plan (opens the original)
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The European regulator argues that drug developers should prioritize generating robust evidence rather than adhering to a fixed trial count standard. Drug trial sponsors should prioritize generating compelling evidence rather than fixating on the number of studies required, according to the European Medicines Agency (EMA). In a recent editorial, the agency referenced the US Food and Drug Administration’s (FDA) “one pivotal study” position in an editorial while sharing its own perspective. EMA ex
Veeva AI agent speeds clinical trial setup (opens the original)
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The technology uses Claude LLM and CDISC standards to configure EDC forms and schedule visits within 24 hours for existing Veeva EDC customers. Clinical trial technology firm Veeva Systems has developed an AI agent that allows sponsors to configure data capture and quality systems directly, based on study protocols. The agentic technology— called Study Builder — uses existing data standards and leverages the CDISC Unified Study Definitions Model (USDM) to build studies faster than manual approac
Trial management tops sourcing for success (opens the original)
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Tufts Center research surveyed 13 biopharma companies to compare internal resources, full-service CROs and functional service provider performance. Program management strategy is a more accurate predictor of whether a clinical study will succeed than the sourcing model selected, according to new analysis from the Tufts Center for the Study of Drug Development. The study surveyed 13 biopharma firms about CRO sourcing and management strategies and found that the latter has a greater bearing on whe
FDA Plans More Overseas Clinical Trial Audits (opens the original)
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Agency cites challenges with unannounced audits abroad and questions whether host nations can match its standards for clinical research oversight. The US Food and Drug Administration (FDA) plans to increase the resources it allocates for overseas clinical trial facility inspections and update the risk-based criteria used to select research sites for audit. The US drug industry regulator outlined the plan in a blog post last week, in which it also raised concerns about regulatory capacity and cap
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